Caroline Byrd

Dir. Commercial Regulatory Affairs & Quality Assurance, Leica Biosystems

Caroline Byrd has worked in the medical device industry for over 18 years holding various leadership positions in Regulatory, Quality, R&D, and Operations for small private companies and large corporations. She is currently a Director of Regulatory Affairs, based in Minnesota, focused on strategic EU Medical Device Regulation (MDR) implementation. Since 2016, Caroline has worked cross-functionally to scope the impacts of the MDR to Abbott Medical Device Division’s portfolio, quality and IT systems, and supply chain. Prior to her full time focus on the EU MDR, Caroline led the Clinical Evaluation, Preclinical, and Biocompatibility organizations for St. Jude Medical. Caroline is also a champion for product lifecycle management concepts and data management solutions that enable value-add compliance to regulation. She holds a BS in Mechanical Engineering from Washington University in St. Louis.

Tell Us Something Interesting:

I am leading implementation of the Medical Device Regulations at my company and I am very interested in collaborating on PLM and data management solutions bein pursued to manage a lot of data that must be pushed to external worldwide databases.

Session Track: Life Sciences

Tuesday, June 11 2:15 PM - 3:00 PM 209

LS113P - Preparing for EU-MDR: Insights from Medical Device Leaders

The medical device industry is facing a wave of regulatory challenges, including EUMDR, GDPR, and Single Audit Program (MDSAP). The EUMDR 2020 deadline for the first wave of devices is rapidly approaching, and companies are moving from planning to action. Learn how life sciences leaders are rising to the challenge in this panel discussion. Panelists will explore a range of approaches for tackling common compliance challenges and highlight similarities and differences across companies.

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